To determine the effect of the application of vibration and exercise on shoulder pain for patients after laparoscopic cholecystectomy
Design
The true experimental design was employed to achieve the aforementioned objectives. patients will be allocated into two groups study and control (each group with 35 cases) in the study group patients is given exercise and vibration The total sample size would be 70 patients.
Settings and conduct
70 patients with shoulder pain after surgery, were visiting the surgery ward in one major teaching hospital in Baghdad City. Study subjects were recruited when they were seeking the follow-up of their health problems and prescriptions refilling. The simple randomization procedure would involve throwing a dice (eg, below & equal to 3 = control, over 3 = study group). No allocation concealment will be carried out.
Participants/Inclusion and exclusion criteria
Inclusion: *Consent & compliance with all aspects of the study protocol, and methods, and providing data during the follow-up phase.
Exclusion: *Medically diagnosed with shoulder pain
Intervention groups
The starting point for the intervention phase will be to ask the patient after two hours from laparoscopic cholecystectomy 'Do you have shoulder pain'. If say yes give a score of pain from 0-10 as a numerical pain scale, this mandatory step will help to identify the severity of patients' pain before and after applying the vibration by a reliable device and stander exercise for the shoulder.
Main outcome variables
Minimizing or relief the shoulder pain after laparoscopic cholecystectomy
General information
Reason for update
Acronym
A Randomized clinical trial (ARCT)
IRCT registration information
IRCT registration number:IRCT20230310057672N1
Registration date:2023-03-30, 1402/01/10
Registration timing:prospective
Last update:2023-03-30, 1402/01/10
Update count:0
Registration date
2023-03-30, 1402/01/10
Registrant information
Name
Alaa Jawad
Name of organization / entity
University of Baghdad/College of Nursing
Country
Iraq
Phone
+964 1 521 1494
Email address
alaaj@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-02, 1402/01/13
Expected recruitment end date
2023-05-13, 1402/02/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vibration and Exercise on Shoulder Pain for Patients after Laparoscopic Cholecystectomy : A Randomized Clinical Trial
Public title
Vibration and Exercise Maneuvers to Minimize Patients’ shoulder pain post lap chole: A Randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent & compliance with all aspects of the clinical trial, methods, providing data during follow-up phase
Contact male & female patients, who are 18-70 years old at the time of the data collection phase
Exclusion criteria:
Involvement with any other ongoing studies.
Medically diagnosed with psycho-mental diseases.
Patients who suffer from shoulder pain before undergoing laparoscopic cholecystectomy
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
In order to maintain a transparent & scientific-based randomization process, simple randomization will be used in assigning participants (patients with shoulder pain), to intervention & control groups, assuming that each participant has an equal chance of being assigned to any group. The simple randomization procedure would involve throwing the dice (eg, below & equal to 3 = control, over 3 = intervention). No allocation concealment will be carried out.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Approval Committee, at the College of Nursing
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Approval date
2022-12-07, 1401/09/16
Ethics committee reference number
4499
Health conditions studied
1
Description of health condition studied
Pain in Shoulder after laparoscopic cholecystectomy
ICD-10 code
M25.519
ICD-10 code description
Pain in unspecified shoulder
Primary outcomes
1
Description
Shoulder Pain after Laparoscopic Cholecystectomy (Relief or Minimize)
Timepoint
The clinical intervention of the experiment is carried out two hours after the laparoscopic gallbladder removal operation for patients, and the results of the intervention appear to reduce the intensity of shoulder pain from the first postoperative day to the third day.
Method of measurement
Measurement method before and after clinical intervention using a numerical pain scale to measure shoulder pain
Secondary outcomes
1
Description
Minimize Patients’ shoulder pain post lap chole
Timepoint
The secondary outcome is measured following the application of intervention and after 2-4 hours on the same day of intervention
Method of measurement
Interview Method: The patient has shoulder pain after laparoscopic cholecystectomy
Intervention groups
1
Description
Intervention group: The starting point for the intervention phase will be to ask the patient after two hours from laparoscopic cholecystectomy 'Do you have shoulder pain' questionnaire. If say yes give a score of pain from 0-10 as a numerical pain scale, this mandatory step will help to identify the severity of patients' pain before and after applying the vibration by a reliable device and stander exercise for the shoulder (Williams & Wilkins, 2011). We will evaluate the effectiveness of the clinical intervention on the same first day after laparoscopic cholecystectomy to the third day.
Category
Other
2
Description
Control group: In order to be matched with patients in the intervention group, control group subjects with shoulder pain after laparoscopic cholecystectomy will be determined. No intervention will be given to them during the study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgical ward in AL-Kindi Teaching Hospital and Baghdad Teaching Hospital
Full name of responsible person
Alaa Jawad Kadhim, Noorah Mahmoud Ali
Street address
Bab AL-Muadum Medical Teaching Hospitals
City
Baghdad
Postal code
10001
Phone
+964 1 415 0076
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Professor Huda Baker Hassan, PhD. Dean
Street address
Bab AL-Muadum campus
City
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://en.conursing.uobaghdad.edu.iq/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Al Rasafa, New Baghdad, House No 19/20, Street No 77, Section No 729
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://mapcarta.com/30678848
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Al Rasafa, New Baghdad, House No 19/20, Street No 77, Section No 729
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://mapcarta.com/30678848
Person responsible for updating data
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Al Rasafa, New Baghdad, House No 19/20, Street No 77, Section No 729
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://en.conursing.uobaghdad.edu.iq/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis, and successful publishing of the manuscript, all the related files will become available for Five months after the publications
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: alaaj@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
N/A
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors.